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June 24, 2011

Tobira Launches Phase II Study of Entry Inhibitor Cenicriviroc

Tobira Therapeutics is recruiting for a Phase IIb study of its CCR5/CCR2 entry inhibitor cenicriviroc (TBR-652). It is hoped that cenicriviroc will not only offer people a new antiretroviral (ARV) option to keep HIV in check, but that it will also prove useful in reducing the cellular inflammation that scientists believe is behind a host of health problems.

Cenicriviroc is from a class of drugs that blocks the CCR5 coreceptor on CD4 cells, thus making them resistant to HIV infection. It is in the same class of drugs as Selzentry (maraviroc) but may be used once-daily instead of twice-daily.

Cenicriviroc also has another unique attribute. In addition to blocking the CCR5 coreceptor, it also blocks another coreceptor called CCR2, which is involved in inflammatory diseases such as rheumatoid arthritis. In recent years, researchers have shown that cellular inflammation, even in people whose HIV is well controlled by ARV therapy, may contribute to a number of health problems, including cardiovascular disease. It is hoped, though it will take time to prove this, that cenicriviroc will be a dual-purpose drug—fighting HIV directly while also reducing HIV-related inflammation.

According to Tobira press materials, the new study will pit cenicriviroc against Sustiva (efavirenz), both of them paired with Truvada (tenofovir plus emtricitabine). Tobira will be studying two doses of cenicriviroc, 100 milligrams (mg) and 200 mg once-daily.

“This study is based on the strength of the cenicriviroc Phase IIa proof of concept, pharmacokinetic and safety findings that were presented at key HIV/AIDS conferences and published in peer‐reviewed journals,” said Melanie Thompson, MD, of the AIDS Research Consortium of Atlanta, and a lead investigator in the Phase IIb study. “The study will further explore cenicriviroc’s antiviral activity and safety as well as effects on immunologic and inflammatory biomarkers, including the effects of CCR2 receptor inhibition in HIV‐1 infected patients.”

To learn more about the cenicriviroc study, visit the clinical trials database run by the National Institutes of Health (NIH).

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